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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054412
Other study ID # IRB-23-02-5477
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2024
Est. completion date March 2026

Study information

Verified date April 2024
Source Wayne State University
Contact Principal Investigator
Phone 313-577-4409
Email hj1429@wayne.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Must have clinically concerning symptoms of Post-traumatic Stress Disorder and/or it's dissociative sub-type, as indicated by either a score of 3+ on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure for PTSD symptoms OR endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the Dissociative Subtype of PTSD Scale (DSPS). - Must be between 3-24 months postpartum - Must be receiving regular, primarily in-person psychotherapy from a therapist at a clinic in the Greater Detroit area. Exclusion Criteria: - Are currently pregnant - Have a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder - Have a documented history of epilepsy - Have ever experienced previous head injury with loss of consciousness - Are currently experiencing domestic or intimate partner violence or otherwise state that their current living conditions are unsafe - Are currently experiencing psychosis or have been suicidal within the last six months - Are currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis - Have engaged in self-harming behaviors in the last 3 months requiring medical attention - Do not have competence to understand or consent to the study procedures - Do not have fluency in written and spoken English

Study Design


Intervention

Device:
Neuroptimal (Zengar, Inc.) Neurofeedback
Mothers in the Neurofeedback Training group will complete one training session (lasting approximately 33 minutes) a week for a total of 12 weeks, using the Neuroptimal (Zengar, Inc.) neurofeedback device.

Locations

Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuro-QoL Item Bank v1.0 - Positive Affect and Well-Being - Short Form To measure maternal well-being. Minimum score = 9 Maximum score = 45 Higher scores mean a better outcome. Weekly, throughout the course of the 3-month training phase
Primary Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard) To measure maternal symptoms of PTSD Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Dissociative Experiences Scale II To assess maternal symptoms of dissociation. Minimum score = 0 Maximum score = 100 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Patient Health Questionnaire 8 To measure maternal depressive symptoms. Minimum score = 0 Maximum score = 24 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary The State Trait Anger Expression Inventory To measure maternal anger control. Minimum score = 10 Maximum score = 40 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Brief Child Abuse Potential screener, an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.) The Brief Child Abuse Potential is a screening tool that is an abbreviated version of the Child Abuse Potential Inventory ([CAP]), © 1980, 1986, Joel S. Milner, PhD.). This measure is used to understand a caregiver's potential risk of perpetrating acts of child abuse. The measure includes 33 items; caregiver's endorse whether they "Agree" or "Disagree" with each item. Agree responses are given a score of 1, Disagree responses are given a score of 0.
Minimum score = 0 Maximum score = 33 Higher scores mean a worse outcome.
The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Parenting Stress Index To measure stress associated with parenting. Minimum score = 36 Maximum score = 180 Higher scores mean a better outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Parenting Sense of Competence scale To measure feelings of parental competency and self-efficacy. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary The Crying Patterns Questionnaire To measure infant crying and fussing patterns. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary The Baby Pediatric Symptom Checklist of the Survey of Well-Being for Young Children To measure infant psychosocial wellbeing. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome. The measure will be administered at beginning of the study and again following the completion of the training phase, up to 4 months later.
Primary Neuro-QoL Item Bank v1.0 - Emotional and Behavioral Dyscontrol - Short Form To measure maternal emotional and behavioral self-regulation. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome. Weekly, throughout the course of the 3-month intervention
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